Efavirenz causes neuropsychiatric side effects and sleep disturbance, including vivid dreams, dizziness, and abnormal tiredness. These symptoms are frequent during the first weeks of treatment, with subsequent attenuation but may not completely resolve even years after efavirenz initiation.

The investigators plan a four week, randomized, placebo-controlled, double-blind study. In group 1, efavirenz will be replaced with efavirenz placebo plus raltegravir, in group 2, efavirenz would be continued, and raltegravir placebo given in addition. After two weeks, patients in group 1 would switch to the regimen of group 2, and vice versa.

The primary endpoint of the trial will be patient preference. Sleep quality, daytime sleepiness, and anxiety will also be investigated.

Patient receives raltegravir and efavirenz placebo during the first 2 weeks

Drug: Efavirenz for the last 2 weeks

Patient receives efavirenz and raltegravir placebo during the last 2 weeks

Experimental: Efavirenz first

Patients treated with Efavirenz for first 2 weeks

Drug: Efavirenz for the first 2 weeks

Efavirenz and raltegravir placebo for the first 2 weeks

Drug: Raltegravir for the last 2 weeks

Raltegravir and efavirenz placebo for the last 2 weeks

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Adult patients > 18 years

Signing the study consent form and agree to change ART regimen

Stable HAART including EFV since at least 3 months

HIV-RNA below 50 copies for at least 3 months

Exclusion Criteria:

No major psychiatric disease (psychosis, severe depression) diagnosed before the initiation of EFV

Mentally incompetent patients

Pregnancy or lactation Women of childbearing potential must use one or two reliable contraceptive methods during the trial, from day 1 to the end of week 12. Acceptable methods include the birth control pill, IUD, condoms with spermicides. Non-acceptable methods include (non-exhaustive list): Withdrawal, calendar (Onigo method), or spermicides alone.

Concomitant renal or hepatic disease:

Creatinine above 150 micromol/L

Transaminases above 5 times upper normal limit

Prothrombin (Quick) value below 50%

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00944957